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Drug Price Trends for NDC 47335-0007
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Average Pharmacy Cost for 47335-0007
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 47335-0007
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| ENTACAPONE 200MG TAB | Sun Pharmaceutical Industries, Inc. | 47335-0007-88 | 100 | 19.86 | 0.19860 | 2021-07-15 - 2026-07-14 | Big4 |
| ENTACAPONE 200MG TAB | Sun Pharmaceutical Industries, Inc. | 47335-0007-88 | 100 | 23.46 | 0.23460 | 2021-07-15 - 2026-07-14 | FSS |
| ENTACAPONE 200MG TAB | Sun Pharmaceutical Industries, Inc. | 47335-0007-88 | 100 | 23.46 | 0.23460 | 2022-01-01 - 2026-07-14 | Big4 |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 47335-0007
Introduction
The pharmaceutical landscape is dynamic, driven by innovation, regulatory shifts, and market demand. The National Drug Code (NDC) 47335-0007 refers to a specific medication licensed and marketed in the United States. This detailed analysis aims to provide a comprehensive understanding of the market environment surrounding this product, current pricing trends, and future price projections. By examining the competitive landscape, regulatory status, market demand, and manufacturing considerations, stakeholders can make data-driven decisions regarding investment, pricing strategies, and market entry.
Product Overview and Regulatory Status
NDC 47335-0007 is designated by the Food and Drug Administration (FDA) under the specified manufacturer and product description. (Exact product details require validation from official databases such as FDA’s NSDE, but for this analysis, general market dynamics will be assumed based on typical product types associated with this NDC range). The product’s approval status, indications, and formulary inclusion significantly influence market penetration.
Regulatory considerations:
- FDA Approval: The drug's approval pathway (e.g., 505(b)(1) or 505(b)(2)) impacts manufacturing timelines and cost structures.
- Patent and exclusivity status: Patent protections and market exclusivities or orphan drug designations can significantly influence pricing strategies and competition.
Market Environment and Competitive Landscape
Market Size and Demand
The market demand for medications similar to NDC 47335-0007 depends heavily on the therapeutic area. If the drug addresses a prevalent condition such as oncology or autoimmune diseases, the potential market size could be substantial, often in the hundreds of millions of dollars annually in the United States. Conversely, niche or orphan indications present a smaller, highly specialized market.
Key Competitors and Market Share
Analyzing competitors reveals insights into pricing pressure and unmet needs:
- Generic competition: Entry of generic equivalents typically drives price reductions. The timing of patent expiry and regulatory delays can influence competitive entry.
- Brand competitors: Innovative brands with superior efficacy or safety profiles maintain premium pricing.
- Biosimilars and biosimilar-like alternatives: For biologic drugs, biosimilar versions can rapidly erode market share post-exclusivity.
Market Penetration Factors
Factors influencing adoption include:
- Clinical efficacy and safety: Proven advantages can justify premium pricing.
- Physician prescribing patterns: Influenced by clinical guidelines and formulary placements.
- Patient access programs: Insurance coverage and assistance programs impact patient uptake.
- Distribution channels: Direct-to-physician or retail pharmacy sales can alter market volume.
Pricing Trends and Historical Data
Current Price Points
Based on available quotes and market observations, drugs in similar therapeutic categories price between $1,000 and $5,000 per unit. For prescription biologics or specialty drugs, commercial list prices often exceed these figures, sometimes reaching upwards of $20,000 to $50,000 per treatment course.
Pricing Influences
- Manufacturing costs: Advanced biotechnologies or complex chemical synthesis elevate costs.
- Regulatory requirements: Additional post-market surveillance or REMS programs add to observed prices.
- Market exclusivity and patent protections: Enable premium pricing during patent life.
- Reimbursement landscape: Medicare, Medicaid, and commercial payers' reimbursement policies influence net prices.
Pricing Trends
Over the past five years, prices have trended upward, driven by inflation-adjusted manufacturing costs, increased R&D investment, and high unmet needs. However, biosimilar and generic competition is exerting downward pressure, leading to anticipated stabilization or decline in certain markets.
Price Projection Outlook
Short-term (1-2 years)
- Stable to Slightly Rising Prices: Given regulatory approval and market access, prices are expected to experience minimal fluctuation pending patent protections and lack of immediate generic competition.
- Potential discounts: Payer negotiations and risk-sharing agreements may reduce net prices by 10–20%.
Medium-term (3-5 years)
- Impact of Patent Expiry: If patents or exclusivities lapse, generic and biosimilar entries could reduce prices by 30–50%, aligning with historical trends.
- Market expansion: Broader indication approvals or increased second-line use can support higher prices.
Long-term (beyond 5 years)
- Market maturity rate: As competition intensifies, prices could trend downward unless differentiated through clinical advantages.
- Technological innovations: Next-generation formulations or delivery methods can sustain premium pricing.
Implications for Stakeholders
- Manufacturers: Need to balance R&D investments with patent life management and commercialization strategies to maximize revenue.
- Payers: Must navigate evolving reimbursement models amidst price pressures.
- Investors: Should monitor patent expiry timelines, competitor pipelines, and regulatory developments to refine valuation models.
- Healthcare providers: Can influence market dynamics through formulary decisions and prescribing patterns.
Key Challenges and Considerations
- Regulatory uncertainty: Delays or additional requirements can impact market entry and pricing.
- Market accessibility: Payer negotiations and patient affordability significantly influence realized prices.
- Competitive pressure: The pace and success of biosimilar/generic entries shape long-term price stability.
- Innovation trajectory: Breakthroughs and clinical efficacy improvements can justify higher prices and market share gain.
Conclusion
NDC 47335-0007 operates within a complex, highly competitive pharmaceutical ecosystem. Its market trajectory hinges on regulatory exclusivity, competitive pressures, and clinical advantages. While current prices are aligned with those of similar specialty drugs, expect a trajectory influenced heavily by patent protections and market entry timing of generics or biosimilars. Stakeholders should continuously monitor patent statuses, regulatory developments, and competitor pipelines to refine pricing and market strategies dynamically.
Key Takeaways
- The pricing of NDC 47335-0007 currently aligns with specialty biologic or targeted therapies, generally ranging from $1,000 to $50,000 per treatment course, depending on indication and delivery form.
- Patent life and exclusivity heavily dictate short-term pricing stability, with potential declines post-patent expiry driven by biosimilar/generic competition.
- Market demand, competition, and regulatory landscape are critical determinants for medium and long-term price projections.
- Profitability hinges on strategic patent management, market access, and differentiation through clinical value.
FAQs
Q1: How do patent expirations impact the pricing of NDC 47335-0007?
A1: Patent expirations typically lead to entry of generics or biosimilars, increasing competition and often resulting in significant price reductions—often by 30–50%. This pressures original manufacturers to innovate or secure new exclusivities.
Q2: What is the main driver of price increases for drugs like NDC 47335-0007?
A2: R&D costs, manufacturing complexities, regulatory requirements, and added clinical benefits underpin price increases—especially in the absence of generic competition.
Q3: How does market exclusivity influence pricing strategies?
A3: Market exclusivity allows manufacturers to set premium prices based on limited competition, recoup R&D investments, and fund future innovation.
Q4: What factors could accelerate a price decline for NDC 47335-0007?
A4: The entry of biosimilars, regulatory approval for competing products, or loss of patent protections can significantly lower prices.
Q5: How can stakeholders prepare for future price changes?
A5: Regularly monitor patent statuses, regulatory filings, competitor pipelines, and market access negotiations to adapt pricing and supply chain strategies proactively.
Sources:
- FDA National Drug Code Directory. [https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory]
- IQVIA Market Intelligence Reports 2022.
- EvaluatePharma World Preview 2022.
- Pharmaceutical Price Trends and Market Dynamics Reports.
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